Composition:
Application:
Utilisé dans le traitement:
Examiné médicalement par Oliinyk Elizabeth Ivanovna, Pharmacie Dernière mise à jour le 03.04.2022
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Levsin® / SL (comprimés de sulfate d'hyoscyamine) est efficace comme traitement d'appoint dans le traitement de l'ulcère gastroduodénal. Il peut également être utilisé pour contrôler la sécrétion gastrique, le spasme viscéral et l'hypermotilité dans la colite spastique, la vessie spastique, la cystite, le pylorospasme et les crampes abdominales associées. Peut être utilisé dans les troubles intestinaux fonctionnels pour réduire les symptômes tels que ceux observés dans les dysenteries légères, la diverticulite et l'entérocolite aiguë. À utiliser comme traitement d'appoint dans le traitement du syndrome du côlon irritable (colon irritable, côlon spastique, colite muqueuse) et des troubles gastro-intestinaux fonctionnels. Également utilisé comme traitement d'appoint dans le traitement de la vessie neurogène et des troubles intestinaux neurogènes (y compris le syndrome de flexion splénique et le côlon neurogène). Également utilisé dans le traitement des coliques infantiles (élixir et gouttes). Levsin® / SL (comprimés de sulfate d'hyoscyamine) est indiqué avec de la morphine ou d'autres stupéfiants en soulagement symptomatique des coliques biliaires et rénales; comme «agent desséchant» dans le soulagement des symptômes de la rhinite aiguë; dans la thérapie du parkinsonisme pour réduire la rigidité et les tremblements et pour contrôler la sialorrhée et l'hyperhidrose associées. Peut être utilisé dans le traitement de l'intoxication par des agents anticholinestérase.
Dosage may be adjusted according to the conditions and severity of symptoms. The tablets may be taken sublingually, orally or chewed.
Adults and pediatric patients 12 years of age and older
1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.
Pediatric patients 2 to under 12 years of age: ½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.
Glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis): paralytic ileus, intestinal atony of elderly or debilitated patients; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.
WARNINGS
In the presence of high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Like other anticholinergic agents, Levsin®/SL (hyoscyamine sulfate tablets) may produce drowsiness, dizziness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug.
Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine sulfate. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, euphoria, anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.
PRECAUTIONS
General
Use with caution in patients with: autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, hypertension, and renal disease. Investigate any tachycardia before giving any anticholinergic drug since they may increase the heart rate. Use with caution in patients with hiatal hernia associated with reflux esophagitis.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term studies in animals have been performed to determine the carcinogenic, mutagenic or impairment of fertility potential of Levsin®/SL; however, 40 years of marketing experience with hyoscyamine sulfate shows no demonstrable evidence of a problem.
Pregnancy-Pregnancy Category C
Animal reproduction studies have not been conducted with Levsin®/SL (hyoscyamine sulfate tablets). It is also not known whether Levsin®/SL (hyoscyamine sulfate tablets) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Levsin®/SL (hyoscyamine sulfate tablets) should be given to a pregnant woman only if clearly needed.
Nursing Mothers
Levsin®/SL (hyoscyamine sulfate tablets) is excreted in human milk. Caution should be exercised when Levsin®/SL (hyoscyamine sulfate tablets) is administered to a nursing woman.
Geriatric Use
Reported clinical experience has not identified differences in safety between patients aged 65 and over and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
All of the following adverse reactions have been reported with hyoscyamine sulfate. Adverse reactions may include dryness of the mouth; urinary hesitancy and retention; blurred vision; tachycardia; palpitations; mydriasis; increased ocular tension; loss of taste; headache; nervousness; drowsiness; weakness; fatigue; dizziness; insomnia; nausea; vomiting; impotence; constipation; bloated feeling; abdominal pain; diarrhea; allergic reactions or drug idiosyncrasies; urticaria and other dermal manifestations; ataxia; speech disturbance; some degree of mental confusion and/or excitement (especially in elderly persons); short-term memory loss; hallucinations; and decreased sweating.
The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation.
Measures to be taken are immediate lavage of the stomach and injection of physostigmine 0.5 to 2 mg intravenously and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (tepid water sponge baths, hypothermic blanket). Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.
In rats, the LD50 for hyoscyamine is 375 mg/kg. Levsin®/SL (hyoscyamine sulfate tablets) is dialyzable.